JP7274614B2 - wire lock assembly - Google Patents

Description

This application is filed May 3, 2016, U.S. Provisional Application No. 62/331,083 and U.S. Provisional Application No. 62/490,958, filed April 27, 2017. No priority benefit of the specification is claimed, which is hereby incorporated by reference in its entirety.

The present invention is useful in the field of medical procedures, particularly those involving introducer catheters, wire guides, endoscopes, and the like.

Endoscopes are routinely used to perform various medical procedures on body parts that are difficult to see, difficult to access, or require incision for access. In addition, endoscopes often allow visual access to the target anatomy without the use of fluoroscopy. Endoscopes also provide working channels for passing other devices through the endoscope and directly targeting internal body lumens or regions of anatomy. For example, catheters, wire guides, and other types of elongated medical devices are frequently passed through the working channel of an endoscope to perform diagnostics or medical procedures near the distal end of the endoscope.

Wire guides are used during many procedures in the digestive system, including the pancreaticobiliary (ie, biliary), stomach, and esophagus. Wire guides are long, thin, relatively flexible wires used to gain and maintain access to narrow passages in the body during minimally invasive medical procedures. Because wire guides are fairly long, they can be cumbersome and require the physician's constant attention to maneuver.

Wire guides often must be maintained in a fixed position relative to the patient as the physician performs various procedures. In particular, maintaining the wire guide in a fixed position is important to avoid losing access to the target anatomy, such as the ducts of the biliary system. Also, in order to advance one or more dilators over the wire guide, the physician must hold the wire guide firmly in and across the esophageal stricture during esophageal dilation. Similarly, during percutaneous endoscopic gastrostomy (PEG) placement, the wire guide must be fixed relative to the patient's mouth, esophagus, and stomach as the physician inserts the feeding tube. must.

Due to the complexity of these procedures, physicians often require the assistance of another person to hold the endoscope, manipulate the catheter, and/or hold the wire guide. However, this diverts the assistant's focus from other areas of responsibility such as checking the patient, checking the monitor for relevant information, or performing other tasks. Therefore, it is desirable to design medical devices that address these challenges.

In one aspect, a wire lock assembly for an access port of an elongated medical tube is a body having an exterior surface, an interior surface, and a central opening disposed within the body; an attachment mechanism disposed within an exterior surface of the body, the attachment mechanism having an open end and a closed end; and at least one attachment mechanism disposed on the body and positioned proximate the central opening. and at least one seal supported within the interior surface of the body and in communication with the central opening, the seal including a passageway within the seal, the interior surface of the body comprising: Defining a non-linear path for securing one or more medical devices. In some embodiments, one or more medical devices include wire guides. In other embodiments, the non-linear path of the inner surface is defined by one or more bends, one or more medical devices are locked in place by sliding motion, and one or more medical devices are locked in place by flexion. Take a nonlinear path. In a further embodiment, the attachment mechanism includes a ramp and a snap fit mechanism located distal to the ramp. The protrusion may be proximally disposed about the periphery of the attachment mechanism. In some embodiments, the medical device further includes at least one slot for engaging an end of the elongated medical device. An internal surface of the non-linear path may be formed between the upper section and the intermediate section of the body. A pair of snap-fit mechanisms may be positioned within the non-linear path. In alternative embodiments, the inner surface of the body places one or more medical devices into a flexed state.

In another aspect, the wire lock assembly includes a body having an exterior surface, an interior surface, and a central opening disposed within the body; and a mounting tip disposed within the exterior surface of the body. A mechanism, a mounting mechanism having an open end and a closed end, and at least one seal supported within the interior surface of the body and in communication with the central opening, the seal having a passageway therein. and one or more tail lock passages disposed in the body across the central opening, the one or more tail lock passages including an angled interior surface; An interior surface of the body defines a non-linear path for securing one or more medical devices formed between the upper and middle sections of the body. In some embodiments, the attachment mechanism has a U-shaped configuration.

In another aspect, a system for retaining a wire guide is an endoscope having an access port and a wire lock assembly secured to the access port, wherein the medical device is a body and has an exterior surface and an exterior surface. a body having: an interior surface; a central opening disposed within the body; and a tail lock passage disposed within the body across the central opening, the tail lock passage including an angled interior surface. and a wire lock assembly including the above tail lock passage, wherein the interior surface of the body defines a non-linear path for securing the wire guide.

Fig. 2 shows a front perspective view of one embodiment of a wire lock assembly; 4 shows a wire guide positioned within a wire guide locking slot of a wire lock assembly; 4 shows a wire guide positioned within a wire guide docking slot of a wire lock assembly; FIG. 11 shows a rear perspective view of one embodiment of a wire lock assembly; FIG. 10B shows a bottom view of one embodiment of a wire lock assembly. 1 illustrates one embodiment of an access port. 4 illustrates an exemplary embodiment of an exploded wire lock assembly; Fig. 2 shows a cross-sectional view of one embodiment of a wire lock assembly; Fig. 4 shows a top section of one embodiment of a wire lock assembly; Fig. 4 shows a top section of one embodiment of a wire lock assembly; Figure 3 shows a middle section of one embodiment of a wire lock assembly; Figure 3 shows a middle section of one embodiment of a wire lock assembly; Figure 3 shows the bottom section of one embodiment of a wire lock assembly; Figure 3 shows the bottom section of one embodiment of a wire lock assembly; FIG. 11 shows a cross-sectional view of one embodiment of the wire lock assembly with the wire guide in the locked position during use. 10 illustrates one embodiment of a wire lock assembly attached to an access port; 4 illustrates an embodiment of a method of using an embodiment of a wire lock assembly; Fig. 2 shows a front perspective view of one embodiment of a wire lock assembly; FIG. 10B illustrates a rear perspective view of one embodiment of a wire lock assembly for use with a second medical device; FIG. 10B illustrates a bottom view of one embodiment of a biopsy cap for use with a second medical device; 1 illustrates one embodiment of an access port. FIG. 10B illustrates a cross-sectional view of one embodiment of a wire lock assembly for use with a second medical device; 10 illustrates one embodiment of a wire lock assembly attached to an access port; FIG. 11 illustrates a front perspective view of one embodiment of a wire lock assembly. FIG. 10B illustrates a rear perspective view of one embodiment of a wire lock assembly for use with a second medical device; FIG. 10B illustrates a bottom view of one embodiment of a wire lock assembly for use with a second medical device; 1 illustrates one embodiment of an access port. FIG. 10B illustrates a cross-sectional view of one embodiment of a wire lock assembly for use with a second medical device; 10 illustrates one embodiment of a wire lock assembly attached to an access port; 4 illustrates an exemplary embodiment of an exploded wire lock assembly; Figure 3 shows a middle section of one embodiment of a wire lock assembly; Figure 3 shows a middle section of one embodiment of a wire lock assembly; 1 illustrates one embodiment of a wire lock assembly; 1 illustrates one embodiment of a wire lock assembly; Figure 10 shows an alternative embodiment of a seal for use with a wire lock assembly; Figure 10 shows an alternative embodiment of a wire lock assembly for use with a second medical device; Figure 10 shows an alternative embodiment of a wire lock assembly for use with a second medical device; FIG. 10B illustrates a rear perspective view of one embodiment of a wire lock assembly for use with a second medical device; FIG. 10B illustrates a rear perspective view of one embodiment of a wire lock assembly for use with a second medical device; FIG. 10B illustrates a side view of one embodiment of a wire lock assembly for use with a second medical device; FIG. 10B illustrates a cross-sectional view of one embodiment of a wire lock assembly for use with a second medical device; FIG. 11 illustrates a cross-sectional view one embodiment of a wire lock assembly for use with a second medical device; 4 illustrates an exemplary embodiment of an exploded wire lock assembly;

The present invention will be described with reference to the drawings in which like elements are numbered the same. The relationship and functioning of the various elements of this invention are better understood with the following detailed description. However, the embodiments of the invention described below are merely examples, and the invention is not limited to the embodiments shown in the drawings. It should also be understood that the drawings are not to scale and, in certain instances, details not necessary for an understanding of the invention, such as conventional manufacturing and assembly details, have been omitted.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, this document, including definitions, will control. Although preferred methods and materials are described below, methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

“comprise(s)”, “include(s)”, “have”, “has”, “can”, “contain(s)” ))" and variations thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not exclude the possibility of additional acts or constructions. there is The present invention “comprising,” “consisting of,” and “substantially” the embodiments or elements described herein, whether explicitly recited or not. Other embodiments are also contemplated, consisting essentially of.

The terms "about" or "substantially" when used with respect to an amount refer to the amount recited, such as an amount not substantially different from the recited amount for its intended purpose or function. Includes equal enumerated amounts of variation.

The term "endoluminal" refers to or describes the interior or interior of lumens, ducts, and other passageways or cavities within the human or other animal body. A lumen or body passageway may be an existing lumen or a lumen created by surgical intervention. As used herein, the terms "lumen" or "body passageway" and "vessel" have a broad meaning and refer to any vessel within the human body. e.g., natural or iatrogenic) or cavities, and may include urethra and ureters, blood vessels, respiratory tracts, gastrointestinal tracts, e.g., bile ducts, intestines, esophagus, pericardial cavity, thoracic cavity, etc. Not limited. Accordingly, the term "endoluminal device" or "endoluminal prosthesis" may be placed within or within any such lumen or duct. Refers to a device that can be moved within a vessel.

The terms “patient,” “subject,” and “recipient” as used in this application can mean any animal, especially humans.

The term "medical device" refers to any object per se or component, including structure, that is intentionally inserted into a patient's body as part of a treatment and adapted for introduction into the patient. means any object, including The medical device is a catheter, wire guide, forceps, scissors, or the like used to perform a surgical procedure at a patient treatment site and/or to deliver a second medical device to the patient treatment site. can be tools that are not limited to these.

The terms "proximal" and "distal" are used to describe opposite axial ends of the wire lock and axial ends of various component features. The term "proximal" is used to refer to the end of the medical device (or component thereof) closest to the operator during use of the system. The term "distal" is used to refer to the end of the medical device (or component thereof) that is first inserted into the patient or that is closest to the patient during use.

The term "ramp" is used to describe an angularly inclined ramp or sloping plane used to connect one surface to another, with one end higher than the other. used. The term "slope" is intended to have a broad meaning and may have a varying slope, slope being the difference in height between its two ends, i.e. the vertical rise equal to the length divided by the horizontal distance (run). A "ramp" may have a linear or non-linear configuration.

A more detailed description of the embodiments will now be provided with reference to FIGS. 1A-35. The present invention is not limited to the illustrated embodiments and specifically contemplates other embodiments, not illustrated but intended to fall within the scope of the claims.

Generally, FIG. 1A shows one embodiment of a wire lock assembly 10. As shown in FIG. In this embodiment, wire lock assembly 10 includes a body 12 having a quasi-hemispherical shape. The body 12 of the wire lock assembly 10 may be shaped in a particular configuration, the wire lock assembly having a bottom section 14, a middle section 16 and a top section 18. As shown in FIG. However, in alternate embodiments, body 12 of wire lock assembly 10 may include other geometries. As shown in this embodiment, the central passageway 20 is disposed within the body 12 of the wire lock assembly 10 and accommodates a wire guide, catheter, or similar type elongated medical device (hereinafter "wire guide"). collectively). Within the body 12 of the wire lock assembly is a non-linear wire guide locking passage 13 leading to a wire guide locking slot 15 for the wire guide. When the wire lock assembly 10 is attached to a medical device such as an endoscope, wire guides that extend into the working channel of the medical device may also extend into the central passageway 20 . In this position the wire guide can be placed within the non-linear wire guide locking path 13 . Body 12 of wire lock assembly 10 includes a notch 22 located within upper section 18 of body 12 . Notch 22 helps facilitate positioning of the wire guide within a non-linear wire guide locking path formed within body 12 of wire lock assembly 10 .

The body 12 of the wire lock assembly 10 further includes two side wings 24,26 containing wire guide tail locks 28,30. Side wings 24, 26 allow a user to grasp the surface to attach and remove wire lock assembly 10 from a port of a medical device. As shown, side wings 24, 26 have generally rounded surfaces. However, those skilled in the art will appreciate that other configurations may be used for the side wings. Wire guide tail locks 28 , 30 are located within body 12 of wire lock assembly 10 and are located on opposite sides of body 12 of wire lock assembly 10 . In some embodiments, wire guide tail locks 28, 30 may include a single opening or multiple openings. The wire guide tail locks 28, 30 allow the locked wire guide to loop over the body 12 of the wire lock assembly 10 and be locked in a downward or upward position.

FIG. 1B shows an exemplary embodiment of a wire lock assembly in which wire guide 32 is positioned within non-linear path 13 and wire guide locking slot 15. FIG. In this locked position, the non-linear path 13 and wire guide locking slot 15 cause a three-point bending of the wire guide 32 which automatically positions the wire guide in the locked position. As explained below, the configuration of the non-linear wire guide locking track prevents the wire guide from being damaged because the wire guide is not pinched between the opposing surfaces of the wire guide locking track. Further, after passing through the wire guide locking path 13 and being positioned within the wire guide locking slot 15, the wire guide is automatically in the locked position.

FIG. 1C shows wire guide 32 positioned within wire guide docking slot 30 . As shown in FIG. 1C, the ends of the wire guides 32 are fixed in position to prevent inadvertent contact with a loose guidewire. In use, wire guides may be placed on either side of the wire lock assembly to increase the space available for the user to adjust the device in use with the wire lock.

2 shows a rear perspective view of the wire lock assembly 10. FIG. As shown, wire lock assembly 10 includes a pair of opposing wire guide docking slots 28, 30, a pair of second wire guide locks 34, 36, an attachment mechanism 38, and wire lock assembly 10. a seal 40 disposed within the body 12 of the . Attachment mechanism 38 facilitates connection between wire lock assembly 10 and a port of a second medical device. In this embodiment, attachment mechanism 38 is configured to engage a port of an endoscope. As shown, attachment mechanism 38 includes a groove 42 formed in bottom section 14 of wire lock assembly 10 . A securing mechanism, such as a snap-fit locking mechanism 44, is provided within groove 42 of attachment mechanism 38 to provide a more secure fit between the medical device and the port of the second medical device. Alternate embodiments may include other types of securing mechanisms including, but not limited to, friction fasteners, press fit fasteners, mechanical fasteners, and plastic screws. A protrusion 46 having a thickness relative to the body 12 of the wire lock assembly 10 is positioned below the attachment mechanism 38 . In this embodiment, projection 46 has a quasi-hemispherical configuration and includes an edge 47 that extends beyond the perimeter of groove 42 of attachment mechanism 38 . Protrusions 46 help prevent unwanted rotation of the wire lock assembly relative to the housing of the second medical device. The dimensions of attachment mechanism 38 and protrusion 46 may vary based on the dimensions of the second medical device.

The seal 40 is in fluid engagement with the central passageway 20 of the wire lock assembly 10 to allow working of a second medical device without impeding insertion or movement of a wire guide, catheter or similar elongated device. It is configured to restrict leakage of any fluid that may be present within the channel. This configuration can be particularly advantageous in preventing bodily fluids such as bile and blood from leaking out and contaminating the physician and the working environment. The design and construction of seal 40, including the types of materials from which seal 40 may be manufactured, are well known to those skilled in the art. In this embodiment, seal 40 is positioned between bottom portion 14 and middle portion 16 of wire lock assembly 10 . Although the exemplary seal 40 may include a single slit, other types of slits, split holes, positioned slits, or penetrable seals may alternatively be used. For example, other sealing configurations include duckbills, slitted membranes (e.g., polystyrene, silicone, or another resilient polymeric material), or seals around catheters and wire guides, allowing any proximally moving fluid to pass through the channel. There are other designs that have the ability to prevent . The seal 40 of this embodiment includes two generally planar surfaces.

Referring again to FIG. 2, two second wire guide locks 34,36 are positioned adjacent the wire guide docking slots 28,30 of the wire lock assembly 10 and located in the bottom section 14 of the wire lock assembly 10. It is As shown, the second wire guide locks 34, 36 include clamps having a generally c-shaped design. In alternate embodiments, other configurations may be suitable. In use, when the wire guide is locked in an outwardly facing position within the wire guide locking slot, the proximal portion of the wire guide moves away from the user into one of the second wire guide locks 34,36. may be placed. Placing the proximal portion of the wire guide in one of the second wire guide locks 34, 36 automatically locks the wire guide into a locked position when placed in the wire guide locking slot 15. It provides a secondary lock for the wire guide when deployed.

3 shows a bottom view of the wire guide lock assembly 10. FIG. As shown, wire guide locking assembly 10 includes a pair of opposite tail locks 28, 30, a pair of second wire locks 34, 36, an attachment mechanism 38, and a main body of wire lock assembly 10. and a seal 40 disposed within 12 . A snap-fit locking mechanism 44 is provided within groove 42 of attachment mechanism 38 to provide a more secure fit between the medical device and the port of the second medical device. A protrusion 46 having a thickness relative to the body 12 of the wire lock assembly 10 is positioned below the attachment mechanism 38 . The seal 40 is configured to limit leakage of any fluid that may exist within the working channel of the second medical device without impeding insertion or movement of a wire guide, catheter or similar elongate device. there is

FIG. 4 shows a cross-sectional view of an exemplary access port 48 of an endoscope. Access port 48 provides access to a working channel (not shown) that extends distally through the interior of the endoscope. The metal insert 48 may be covered by an access port cover, which may be removed to access the access port of the metal insert. Access port 48 includes a base 50 and a stem 52 having a height and a width. In some embodiments, access port 48 has a generally t-shaped configuration. Those skilled in the art will appreciate that ports having other types of configurations may also be used.

FIG. 5 shows an exemplary embodiment of the wire lock assembly 10 disassembled. Wire lock assembly 10 is in three parts formed of a suitable material such as plastic. The material may be molded into a particular configuration, and the wire lock assembly 10 has a bottom section 14, a middle section 16 and a top section 18. As shown in FIG. A seal 40 is provided within the body 12 of the wire lock assembly 10 . In this embodiment, seal 40 is secured between middle section 16 and bottom section 14 of wire lock assembly 10 and is in fluid communication with central passageway 20 of wire lock assembly 10 . O-rings 54 are located in areas surrounding the wire guide tail locks 28 , 30 on opposite sides of the wire lock assembly 10 . Middle section 16 and upper section 18 may include molded areas for receiving O-rings 54 within the body of wire lock assembly 10 . The O-ring 54 provides some tactile feedback and friction to the user while the wire guide is positioned within one of the wire guide tail locks 28,30. In this embodiment, a pair of O-rings 54 are positioned near each wire guide tail lock. Alternate embodiments may use different combinations of O-rings. In further alternative embodiments, other mechanical gaskets may be used to provide tactile feedback and friction to the user. Although the exemplary embodiment shown here is constructed from three pieces that snap together, the wire lock assembly 10 can be made from one or more pieces that can be secured together in any manner. good. For example, the parts may be ultrasonically bonded, thermally bonded, bonded together, or secured in any other manner.

FIG. 6 shows a cross-sectional view of the wire lock assembly 10. As shown in FIG. As shown, wire lock assembly 10 includes a central passageway 20 , an attachment mechanism 38 , and a seal 40 disposed within body 12 of wire lock assembly 10 . The upper portion 18 and middle portion 16 of the wire lock assembly form a wire guide locking passage 13 which opens into the wire locking slot 15 . The wire guide locking path 13 includes a raised surface 56 located in the intermediate section 16 of the wire lock assembly. A raised rounded surface 56 extends around the periphery of the central channel 20 and has a generally semi-hemispherical shape. As shown, the raised rounded surface includes a taper extending from the central passageway 20 to the outer peripheral edge of the intermediate section 16 . The tapered section of raised rounded surface 56 increases in diameter as it widens toward the outer periphery of intermediate section 16 . Raised rounded surface 56 includes a tapered, generally rounded surface extending around the perimeter of the intermediate opening. The wire lock assembly 10 further includes a flat edge 58 located in the intermediate section 16 of the wire lock assembly. When the wire guide is secured within the wire guide locking slot, the flat edge 58 serves as a wedge between the wire guide and catheter as the user pulls the catheter up to perform a catheter exchange. may be There is an angled ramp 60 in the groove 42 of the attachment mechanism 38 of the wire lock assembly 10 . The angled ramp 60 allows the wire lock assembly 10 to be secured to a second medical device by sliding the wire lock assembly 10 over the port of the second medical device.

7A shows a perspective view of the exterior surface of the upper section 18 of the wire lock assembly 10. FIG. A top opening 62 is located in the exterior surface of the top section 18 . The upper opening 62 forms the entrance to the central passageway 20 of the body 12 of the wire lock assembly. Notch 22 of wire lock assembly 10 is shown in fluid communication with upper opening 62 . As shown, cutout 22 has a generally triangular configuration. However, those skilled in the art will appreciate that other suitable configurations may be used to form cutout 22 . Notch 22 helps facilitate positioning of the wire guide within a non-linear wire guide locking track formed within the body of the wire lock assembly. The dimensions of the cutout 22 of the wire lock assembly 10 may be determined based on the dimensions of the wire guide or other medical device used with the wire lock assembly. Openings 64 and 66 for the wire guide tail locks 28, 30 are located in the upper section 18 and on opposite sides. A wire guide locking slot 15 is located at the outer edge of the wire lock assembly 10 .

7B shows a perspective view of the inner surface of upper section 18 of wire lock assembly 10. FIG. In this embodiment, the inner surface of the upper section of the medical device may include a molding that mates with the features of the middle section. The notch is in fluid communication with the top opening of the top section of the medical device. A pair of O-rings 54 are positioned adjacent each wire guide tail lock positioned within the inner surface of the upper section. Wire guide locking slots 15 , 17 made by removing material from the upper section 18 of wire lock assembly 10 are located at opposite ends of wire lock assembly 10 . Wire guide locking slots 15 , 17 are defined by the upper portion of wire lock assembly 10 and extend from upper opening 62 to the outer edge of upper portion 18 of wire lock assembly 10 . Each wire guide locking slot 15 and 17 includes a locking mechanism, such as snap-fit locking mechanism 68, to further facilitate locking of the wire guides. The inner surface of the upper section 18 may further include an overmolding material 70 disposed in areas adjacent to the wire guide locking slots 15, 17 that may facilitate ease of use and protection of the wire guides. Overmold material 70 may be manufactured from a suitable resilient material. In a preferred embodiment, overmold material 70 may comprise a thermoplastic elastomeric material. In alternative embodiments, top portion 18 may be formed without overmold material 70 .

8A and 8B show perspective views of top surface 71 and bottom surface 73, respectively, of middle section 16 of wire lock assembly 10. FIG. 8A, middle section 16 is in fluid communication with upper opening 62 in upper section 18 of the wire lock assembly to form a central passageway when upper section 18 and middle section 16 are secured together. includes an intermediate opening 72 for As shown, intermediate section 16 includes a raised generally rounded surface 56 extending around a section of the periphery of intermediate opening 72 . Raised rounded surface 56 includes a taper and extends from intermediate opening 72 to the edge of the intermediate section. When the intermediate section 16 is mated with the upper section 18 of the wire lock assembly 10, the space created by the tapered raised rounded surface 56 and the upper section 18 of the wire lock assembly 10 provides a non-linear wire guide path. It is formed. Middle section 16 of wire lock assembly 10 further includes flat edge 58 positioned adjacent middle opening 72 . The intermediate section 16 further includes a cavity 75 on the opposite side for receiving the wire guide when the wire guide is placed in the wire guide locking tail lock. Openings 77, 79 for wire guide tail locks 28, 30 are located in the middle section 16 and are located on opposite sides. A shaping element 76 is located on the opposite side of the top surface 71 of the intermediate section 16 . Molded elements 76 are configured to engage corresponding elements of upper section 18 of wire lock assembly 10 . Referring now to FIG. 8B, bottom section 73 of middle section 16 includes well 74 for housing seal 40 . A molding element 78 is located on the opposite side of the bottom surface 73 of the intermediate section 16 . Molded elements 78 are configured to engage corresponding elements of bottom section 14 of wire lock assembly 10 .

Figures 9A and 9B show an embodiment of the inner surface 81 of the bottom section 14 of the wire lock assembly. Two second wire guide locks 34, 36 are positioned on opposite sides of the wire lock assembly 10, as shown in FIG. 9A. The second wire guide locks 34, 36 comprise clamps having a generally c-shaped design . Attachment mechanism 38 includes a groove 42 formed in bottom section 14 of wire lock assembly 10 . A snap-fit locking mechanism 44 is provided within groove 42 of attachment mechanism 38 to provide a more secure fit between the wire lock assembly and the port of the second medical device. In this embodiment, the interior surface of bottom section 14 of wire lock assembly 10 includes molding 83 that mates with features on bottom surface 73 of intermediate section 16 . Openings 85, 87 for wire guide tail locks 28, 30 are located in the middle section 16 and are located on opposite sides. In an alternative embodiment, the molding may include gussets 89, or other stiffeners, as shown in FIG. 9B.

FIG. 10 shows a cross-sectional view of one embodiment of wire lock assembly 10 with wire guide 32 positioned in a locked position within wire locking slot 15 . As shown, the catheter 33 has been replaced and removed while maintaining the wire guide 32 in its place within the patient. When the wire lock assembly 10 is attached to a second medical device, the wire guide 32 extending into the working channel of the second medical device passes through the seal 40 and the central passageway 20 of the wire lock assembly 10. procrastinate. While in this position, wire guide 32 can be placed within wire guide locking slot 15 . The nonlinear wire guide locking path 13 induces three point bending in the wire guide 32 in regions α, β and γ. When positioned within wire guide locking slot 15, wire guide 32 is automatically positioned in the locked position. This positioning is due to the stiffness or flex resistance of a typical wire guide 32 causing a lateral force to be applied across the wire guide locking slot 15 . This lateral force creates a frictional force between the wire guide 32 and the wire guide locking slot 15 sufficient to impede, limit, or to some extent prevent longitudinal movement of the wire guide. However, the wire guide 32 is not damaged by the wire guide locking slot 15 because the wire guide is not pinched between the opposing surfaces of the wire lock assembly 10 and lateral forces applied to the wire guide are distributed over several locations. . In particular, this arrangement avoids damage to the wire guide, such as stripping, that can be caused by locking the wire guide in the v-shaped slot. The wire guide 32 is further secured internally by using a snap-fit locking mechanism 68 that forces the wire guide 32 to return to a particular configuration due to the properties of the wire guide, as shown in FIG. 7B. Flat edge 58 acts as a wedge between wire guide 32 and catheter 33 when the user pulls catheter 33 in the direction of the arrow to perform a catheter exchange. Thus, upon removal from wire guide locking slot 15, a second catheter may be inserted through wire guide 32 into the patient.

11 shows a rear view of one embodiment of wire lock assembly 10 in a locked position over access port 48 within groove 42 of attachment mechanism 38 of wire lock assembly 10. FIG. A snap-fit locking mechanism 44 located within groove 42 of attachment mechanism 38 engages stem 52 of access port 48 in an area adjacent the base. In addition, snap-fit locking mechanism 44 provides an audible tone to notify the user that wire lock assembly 10 is securely attached to access port 48 . In this locked position, ramp 60 brings stem 52 of access port 48 into close proximity with seal 40 such that the clearance is less than the height of the upper portion of stem 52 . Accordingly , a compressible seal is formed between wire lock assembly 10 and seal 40 when a wire guide and/or catheter is positioned within central passageway 20 of wire lock assembly 10 . The depth and dimensions of projection 46 of wire lock assembly 10 are sized to accommodate base 50 of access port 48 . Similarly, the depth and dimensions of attachment mechanism 38 are sized to accommodate stem 50 of access port 48 .

FIG. 12 shows a flowchart 1200 of method steps for using an exemplary wire lock assembly in an endoscopic procedure, particularly post-cannulated sphincterectomy. This particular exemplary method describes the use of an endoluminal exchange biliary intubation catheter, an endoluminal exchange sphincterotome catheter, and an endoluminal exchange length wire guide. However, it should be understood that a variety of elongated members (eg, wire guides and catheters, among others) can be used with the exemplary wire guide holder. This includes elongate members for biliary or non-biliary applications. In fact, exemplary wire guide holders can be used with a variety of systems, including rapid exchange, monorail, or over-the-wire, peel-away, and/or non-peel-away systems.

A physician may perform an intraducatal exchange as follows. Initially, at step 1202, the physician may prime the intraluminal exchange biliary cannulation catheter by advancing the distal end of the wire guide into the intraducatal exchange port and out the distal end port of the catheter. can. Step 1204 includes inserting the wire guide and catheter through the seal in the wire guide holder, through the access port of the endoscope, and into the working channel of the endoscope. After the wire guide and intubation catheter are ready for intubation of the nipple of Vater, step 1206 intubates the nipple. After intubation, a wire guide and intubation catheter are advanced into the bile duct. At this point, step 1208 is performed by securing one of the wire guide and catheter within the wire guide holder. For example, the wire guide can be placed within the wire guide locking path as shown in FIG. In this position, the non-linear wire guide locking path causes a 3-point bending of the wire guide that automatically positions the wire guide in the locked position. At this point, advancing the catheter relative to the wire guide separates the wire guide and catheter. When the wire guide and catheter are separated, the physician may lose access to the target anatomy by inadvertently displacing the wire guide because the wire guide is secured within the wire guide locking path. You can continue to use the catheter without Additionally, the proximal end of the locked wire guide may be placed in one of the wire guide docking slots so as not to interfere with the physician. A second wire guide lock provides some additional securing of the wire guide. However, the wire guide is fully locked when placed within the wire guide locking path. Upon disassembly of the catheter, the flat edge of the top portion of the medical device acts as a wedge as the catheter is pulled.

FIG. 13 shows another embodiment of wire lock assembly 110 . In this embodiment, wire lock assembly 110 includes body 112 having a quasi-hemispherical shape. The body 112 of the wire lock assembly 110 may be shaped in a particular configuration, the wire lock assembly having a bottom section 114, a middle section 116 and a top section 118. As shown in FIG. However, in alternate embodiments, the body 112 of the wire lock assembly 110 may include other geometries. As shown in this embodiment, a central passageway 120 is disposed within the body 112 of the wire lock assembly 10 to accommodate a wire guide, catheter, or similar type elongated medical device (hereinafter "wire guide"). collectively). Within the body 112 of the wire lock assembly is a non-linear wire guide locking passage 113 leading to a wire guide locking slot 115 for the wire guide. When the wire lock assembly 110 is attached to a medical device such as an endoscope, wire guides that extend into the working channel of the medical device may also extend into the central passageway 120 . In this position, the wire guide can be placed within the non-linear wire guide locking path. Body 112 of wire lock assembly 110 includes a notch 122 located within upper section 118 of body 112 . Notch 122 helps facilitate positioning of the wire guide within a non-linear wire guide locking path formed within body 112 of wire lock assembly 110 . In the exemplary embodiment, the non-linear path 113 and wire guide locking slot 115 create a three-point bending of the wire guide that automatically positions the wire guide in a locked position. As explained below, the configuration of the non-linear wire guide locking track prevents the wire guide from being damaged because the wire guide is not pinched between the opposing surfaces of the wire guide locking track. Further, after traversing the wire guide locking path 113 and being positioned within the wire guide locking slot 115, the wire guide is automatically in the locked position.

The body 112 of the wire lock assembly 110 further includes two side wings 124,126 containing wire guide tail locks 128,130. Side wings 128, 130 allow a user to grasp a surface to attach and remove wire lock assembly 110 from a port of a medical device. As shown, side wings 124, 126 have generally rounded surfaces. However, those skilled in the art will appreciate that other configurations may be used for the side wings. The wire guide tail locks 128 , 130 are located within the body 112 of the wire lock assembly 10 and are located on opposite sides of the body 112 of the wire lock assembly 10 . In some embodiments, wire guide tail locks 128, 130 may include a single opening or multiple openings. The wire guide tail locks 128, 130 allow the locked wire guide to loop over the body 112 of the wire lock assembly 110 and be locked in a lower or upper position.

14 shows a rear perspective view of the wire lock assembly 110. FIG. As shown, the wire lock assembly 110 includes a central passageway 120, a pair of opposing wire guide tail locks 128, 130, a pair of second wire guide locks 134, 136, an attachment mechanism 138, and a seal 140 disposed within the body 112 of the wire lock assembly 110 . Attachment mechanism 138 facilitates connection between wire lock assembly 110 and a port of a second medical device. In this embodiment, attachment mechanism 138 is configured to engage a port of an endoscope. As shown, attachment mechanism 138 includes a groove 142 formed in bottom section 114 of wire lock assembly 110 . A snap-fit locking mechanism 144 is provided within groove 142 of attachment mechanism 138 to provide a more secure fit between the medical device and the port of the second medical device. A protrusion 146 having a thickness relative to the body 112 of the wire lock assembly 110 is positioned below the attachment mechanism 138 . In this embodiment, protrusion 146 has a quasi-hemispherical configuration and includes edge 147 that extends beyond the perimeter of groove 142 of attachment mechanism 138 . The protrusion 146 helps prevent unwanted rotation 110 of the wire lock assembly relative to the housing of the second medical device. The dimensions of attachment mechanism 138 and protrusion 146 may vary based on the dimensions of the second medical device.

The seal 140 is in fluid engagement with the central passageway 120 of the wire lock assembly 110 to allow working of a second medical device without impeding insertion or movement of a wire guide, catheter or similar elongated device. It is configured to restrict leakage of any fluid that may be present within the channel. This configuration can be particularly advantageous in preventing bodily fluids such as bile and blood from leaking out and contaminating the physician and the working environment. The design and construction of seal 40, including the types of materials from which seal 40 may be manufactured, are well known to those skilled in the art. In this embodiment, seal 140 is positioned between bottom portion 114 and middle portion 116 of wire lock assembly 110 . Although the exemplary seal 140 may include a single slit, other types of slits, split holes, positioned slits, or penetrable seals may alternatively be used. For example, other sealing configurations include duckbills, slitted membranes (e.g., polystyrene, silicone, or another resilient polymeric material), or seals around catheters and wire guides, allowing any proximally moving fluid to pass through the channel. There are other designs that have the ability to prevent . The seal 140 of this embodiment includes two generally planar surfaces.

Two wire guide tail locks 134 , 136 are located adjacent the wire guide tail locks 128 , 130 of the wire lock assembly 110 and located in the bottom section 114 of the wire lock assembly 110 . As shown, the second wire guide locks 134, 136 include clamps having a generally c-shaped design. In alternate embodiments, other configurations may be suitable. In use, when the wire guide is locked in an outwardly facing position within the wire guide locking slot, the proximal portion of the wire guide moves away from the user into one of the second wire guide locks 134,136. may be placed. Placing the proximal portion of the wire guide in one of the second wire guide locks 134, 136 automatically locks the wire guide into a locked position when placed in the wire guide locking slot 115. It provides a secondary lock for the wire guide when deployed.

15 shows a bottom view of the wire guide lock assembly 110. FIG. As shown, wire guide locking assembly 110 includes a pair of opposite tail locks 128, 130, a pair of second wire guide locks 134, 136, an attachment mechanism 138, and wire lock assembly 110. and a seal 140 disposed within the body 112 . A snap-fit locking mechanism 144 is provided within groove 142 of attachment mechanism 138 to provide a more secure fit between the medical device and the port of the second medical device. A protrusion 146 having a thickness relative to the body 112 of the wire lock assembly 110 is positioned below the attachment mechanism 138 . Seal 140 is configured to limit leakage of any fluid that may exist within the working channel of the second medical device without impeding insertion or movement of a wire guide, catheter, or similar elongate device. there is

FIG. 16 shows a cross-sectional view of an exemplary access port 148 of an endoscope. Access port 148 provides access to a working channel (not shown) that extends distally through the interior of the endoscope. Metal insert 148 may be covered by an access port cover, which may be removed to access the access port of the metal insert. Access port 148 includes a base 150 and a stem 152 having a height and a width. In some embodiments, access port 148 has a generally t-shaped configuration. Those skilled in the art will appreciate that ports having other types of configurations may also be used.

FIG. 17 shows a cross-sectional view of wire lock assembly 110 . The upper portion 118 and middle portion 116 of the wire lock assembly form a wire guide locking passage 113 leading to the wire locking slot 113 . Wire guide locking path 113 includes a raised surface 156 located in the middle section of the wire lock assembly. A raised rounded surface 156 extends around the periphery of central channel 120 and has a generally semi-hemispherical shape. As shown, the raised rounded surface includes a taper extending from the central channel 120 to the outer peripheral edge of the intermediate section 116 . The tapered section of raised rounded surface 156 increases in diameter as it widens toward the outer periphery of intermediate section 116 . Raised rounded surface 156 includes a tapered, generally rounded surface extending around the perimeter of the intermediate opening. The wire lock assembly 110 further includes a flat edge 158 located in the middle section 116 of the wire lock assembly. When the wire guide is secured within the wire guide locking slot, the flat edge is used as a wedge between the wire guide and the catheter as the user pulls the catheter up to perform a catheter exchange. may There is an angled ramp 160 in the groove 142 of the attachment mechanism 138 of the wire lock assembly 10 . The angled ramp 160 allows the wire lock assembly 10 to be secured to a second medical device by sliding the wire lock assembly 110 over the port of the second medical device.

18 shows a rear view of one embodiment of wire lock assembly 110 in a locked position over access port 148 within groove 142 of attachment mechanism 138 of wire lock assembly 110. FIG. A snap-fit locking mechanism 144 located within groove 142 of attachment mechanism 138 engages stem 152 of access port 148 in an area adjacent the base. Additionally, snap-fit locking mechanism 144 provides an audible tone to notify the user that wire lock assembly 110 is securely attached to access port 148 . In this locked position, ramp 160 brings stem 152 of access port 148 into close proximity with seal 140 such that the clearance is less than the height of the upper portion of stem 152 . Accordingly, when a wire guide and/or catheter is placed within the central passageway 120 of the wire lock assembly 110, a compressible seal is formed between the wire lock assembly 110 and the seal 140. FIG . The depth and dimensions of protrusion 146 of wire lock assembly 110 are sized to accommodate base 150 of access port 148 . Similarly, the depth and dimensions of attachment mechanism 138 are sized to accommodate stem 150 of access port 148 .

FIG. 19 shows another embodiment of wire lock assembly 210 . In this embodiment, wire lock assembly 210 includes body 212 having a quasi-hemispherical shape. The body 212 of the wire lock assembly 210 may be shaped in a particular configuration, the wire lock assembly having a bottom section 214, a middle section 216 and a top section 218. However, in alternate embodiments, the body 212 of the wire lock assembly 210 may include other geometries. As shown in this embodiment, central passageway 220 is disposed within body 212 of wire lock assembly 210 to accommodate a wire guide, catheter, or similar type elongated medical device (hereinafter "wire guide"). collectively). Within the body 212 of the wire lock assembly is a non-linear wire guide locking passage 213 leading to a wire guide locking slot 215 for the wire guide. When the wire lock assembly 210 is attached to a medical device such as an endoscope, wire guides that extend into the working channel of the medical device may also extend into the central passageway 220 . In this position, the wire guide can be placed within the non-linear wire guide locking path. Body 212 of wire lock assembly 210 includes a notch 222 located within upper section 218 of body 212 . Notch 222 helps facilitate positioning of the wire guide within a non-linear wire guide locking path formed within body 212 of wire lock assembly 210 . In the exemplary embodiment, the non-linear path 213 and wire guide locking slot 215 create a three-point bending of the wire guide that automatically positions the wire guide in a locked position. As explained below, the configuration of the non-linear wire guide locking track prevents the wire guide from being damaged because the wire guide is not pinched between the opposing surfaces of the wire guide locking track. Further, after traversing the wire guide locking path 213 and being positioned within the wire guide locking slot 215, the wire guide is automatically in the locked position.

The body 212 of the wire lock assembly 10 further includes two side wings 224,226 that include wire guide tail locks 228,230. Side wings 228, 230 allow a user to grasp a surface to attach and remove wire lock assembly 10 from a port of a medical device. As shown, side wings 224, 226 have generally rounded surfaces. However, those skilled in the art will appreciate that other configurations may be used for the side wings. The wire guide tail locks 228 , 230 are located within the body 212 of the wire lock assembly 210 and are located on opposite sides of the body 212 of the wire lock assembly 210 . In some embodiments, wire guide tail locks 228, 230 may include a single opening or multiple openings. The wire guide tail locks 228, 230 allow the locked wire guide to loop over the body 212 of the wire lock assembly 10 and be locked in a downward or upward position.

20 shows a rear perspective view of wire lock assembly 210. FIG. As shown, the wire lock assembly 210 includes a central channel 220, a pair of opposing wire guide locks 228, 230, a second pair of wire guide locks 234, 236, an attachment mechanism 238, and a wire guide lock. and a seal 240 disposed within the body 212 of the lock assembly 210 . Attachment mechanism 238 facilitates connection between wire lock assembly 210 and a port of a second medical device. In this embodiment, attachment mechanism 238 is configured to engage a port of an endoscope. As shown, attachment mechanism 238 includes a groove 242 formed in bottom section 214 of wire lock assembly 210 . A snap-fit locking mechanism 244 is provided within groove 242 of attachment mechanism 238 to provide a more secure fit between the medical device and the port of the second medical device. A protrusion 246 having a thickness relative to the body 212 of the wire lock assembly 210 is positioned below the attachment mechanism 238 . In this embodiment, protrusion 246 has a quasi-hemispherical configuration and includes edge 248 that extends beyond the perimeter of groove 242 of attachment feature 238 . Protrusions 246 help prevent unwanted rotation of the wire lock assembly relative to the housing of the second medical device. The dimensions of attachment mechanism 238 and protrusion 246 may vary based on the dimensions of the second medical device. As shown in this embodiment, the attachment mechanism is configured to accommodate port stem and base sizes having larger dimensions than the embodiment of FIGS. 1-17. Attachment mechanism 238 includes an angled edge 239 . The angled edge 239 helps prevent the wire lock assembly 210 from rotating over the port of the medical device, so the wire lock assembly 210 may be used in a medical device having a circular housing. It can be advantageous when used in

The seal 240 is in fluid engagement with the central passageway 220 of the wire lock assembly 210 and allows the working channel of the second medical device to be closed without impeding insertion or movement of a wire guide, catheter or similar elongated device. configured to limit leakage of any fluid that may be present therein. This configuration can be particularly advantageous in preventing bodily fluids such as bile and blood from leaking out and contaminating the physician and the working environment. The design and construction of seal 240, including the types of materials from which seal 240 may be manufactured, are well known to those skilled in the art. In this embodiment, seal 240 is positioned between bottom portion 214 and middle portion 216 of wire lock assembly 210 . Although the exemplary seal 240 may include a single slit, other types of slits, split holes, positioned slits, or penetrable seals may alternatively be used. For example, other sealing configurations include duckbills, slitted membranes (e.g., polystyrene, silicone, or another resilient polymeric material), or seals around catheters and wire guides, allowing any proximally moving fluid to pass through the channel. There are other designs that have the ability to prevent . The seal 240 of this embodiment includes two generally planar surfaces.

Two second wire guide locks 234 , 236 are located adjacent the wire guide tail locks 228 , 230 of the wire lock assembly 210 and located in the bottom section 214 of the wire lock assembly 210 . As shown, the second wire guide locks 234, 236 include clamps having a generally c-shaped design. In alternate embodiments, other configurations may be suitable. In use, when the wire guide is locked in an outwardly facing position within the wire guide locking slot, the proximal portion of the wire guide moves away from the user into one of the second wire guide locks 234,236. may be placed. Placing the proximal portion of the wire guide in one of the second wire guide locks 234, 236 automatically locks the wire guide into a locked position when placed in the wire guide locking slot 215. It provides a secondary lock for the wire guide when deployed.

FIG. 21 shows a bottom view of the wire lock assembly. As shown, the wire guide locking assembly 210 includes a pair of opposing wire guide tail locks 228, 230, a second pair of wire guide locks 234, 236, an attachment mechanism 238, and a wire lock assembly. and a seal 240 disposed within the body 212 of 210 . A snap-fit locking mechanism 244 is provided within groove 242 of attachment mechanism 238 to provide a more secure fit between the medical device and the port of the second medical device. A protrusion 246 having a thickness relative to the body 212 of the wire lock assembly 210 is positioned below the attachment mechanism 238 . Seal 240 is configured to limit leakage of any fluid that may exist within the working channel of the second medical device without impeding insertion or movement of a wire guide, catheter, or similar elongate device. there is

FIG. 22 is a cross-sectional view of an exemplary access port 248 of an endoscope. Access port 248 provides access to a working channel (not shown) that extends distally through the interior of the endoscope. Metal insert 248 may be covered by an access port cover, which may be removed to access the access port of the metal insert. Access port 248 includes a base 250 and a stem 252 having a height and a width. In some embodiments, the access port has a generally circular configuration. Those skilled in the art will appreciate that ports having other types of configurations may also be used.

FIG. 23 shows a cross-sectional view of wire lock assembly 210 . The upper portion 218 and middle portion 216 of the wire lock assembly form a wire guide locking passage 213 leading to wire locking slot 213 . Wire guide locking path 213 includes a raised surface 256 located in the middle section of the wire lock assembly. A raised rounded surface 256 extends around the periphery of central channel 220 and has a generally semi-hemispherical shape. As shown, the raised rounded surface includes a taper extending from the central passageway 220 to the outer peripheral edge of the intermediate section 216 . The tapered section of raised rounded surface 256 increases in diameter as it widens toward the outer periphery of intermediate section 216 . Raised rounded surface 256 includes a tapered, generally rounded surface extending around the perimeter of the intermediate opening. The wire lock assembly 210 further includes a flat edge 258 located in the middle section 216 of the wire lock assembly. When the wire guide is secured within the wire guide locking slot, the flat edge is used as a wedge between the wire guide and the catheter as the user pulls the catheter up to perform a catheter exchange. may There is an angled ramp 260 in the groove 242 of the attachment mechanism 238 of the wire lock assembly 10 . The angled ramp 260 allows the wire lock assembly 210 to be secured to a second medical device by sliding the wire lock assembly 210 over the port of the second medical device.

24 illustrates a rear view of one embodiment of wire lock assembly 210 in a locked position over access port 248 within groove 242 of attachment mechanism 238 of wire lock assembly 210. FIG. A snap-fit locking mechanism 244 located within groove 242 of attachment mechanism 238 engages stem 252 of access port 248 in an area adjacent the base. Additionally, snap-fit locking mechanism 244 provides an audible tone to notify the user that wire lock assembly 210 is securely attached to access port 48 . In this locked position, ramp 260 brings stem 252 of access port 248 into close proximity with seal 240 such that the clearance is less than the height of the upper portion of stem 252 . Accordingly, when a wire guide and/or catheter is positioned within central passageway 220 of wire lock assembly 210 , a compressible seal is formed between wire lock assembly 210 and seal 240 . The depth and dimensions of protrusion 246 of wire lock assembly 210 are sized to accommodate base 250 of access port 248 . Similarly, the depth and dimensions of attachment mechanism 238 are sized to accommodate stem 250 of access port 248 .

FIG. 25 shows another exemplary embodiment of a wire lock assembly disassembled. Wire lock assembly 310 with body 312 is in three parts formed of a suitable material such as plastic. The material may be molded into a particular shape, and the wire lock assembly 310 has a bottom section 314, a middle section 316 and a top section 318. As shown in FIG. The body 312 of the wire lock assembly 310 further includes two side wings 324,326 that include wire guide tail locks 328,330. Body 312 of wire lock assembly 310 includes a notch 322 located within upper section 318 of body 312 . Notch 322 helps facilitate positioning of the wire guide within a non-linear wire guide locking path formed within body 312 of wire lock assembly 10 . An O-ring 354 is located in the area surrounding the wire guide tail locks 328 , 330 on opposite sides of the wire lock assembly 310 . Middle section 316 and upper section 318 may include molded areas for receiving O-ring 354 within the body of wire lock assembly 310 . The O-ring 354 provides some tactile feedback and friction to the user while the wire guide is positioned within one of the wire guide tail locks 328,330. In this embodiment, a pair of O-rings 354 are positioned near each wire guide tail lock. Alternate embodiments may use different combinations of O-rings. In further alternative embodiments, other mechanical gaskets may be used to provide tactile feedback and friction to the user. The wire lock assembly 310 may further include an overmolding material 370 located in an area adjacent the wire guide locking slot that may facilitate ease of use and protection of the wire guide. Overmold material 370 may be made from a suitable resilient material. In a preferred embodiment, overmold material 370 may comprise a thermoplastic elastomeric material. In alternative embodiments, top portion 318 may be formed without overmold material 370 . Although the exemplary embodiment shown here is constructed from three pieces that snap together, wire lock assembly 310 may be made from one or more pieces that may be secured together in any manner. good. For example, the parts may be ultrasonically bonded, thermally bonded, bonded together, or secured in any other manner.

The wire assembly 310 is secured within the body of the wire lock assembly 310 between the middle section 316 and the bottom section 314 of the wire lock assembly 310 to provide fluid communication between the central passageway 320 of the wire lock assembly 310 and the fluid. It includes a first seal 340 and a second seal 341 in communication. In this embodiment, the first seal 340 is in fluid engagement with the central passageway 320 of the wire lock assembly 310 without impeding insertion or movement of a wire guide, catheter or similar elongated device. It is configured to limit any fluid leakage that may exist within the working channel of the second medical device. This configuration can be particularly advantageous in preventing bodily fluids such as bile and blood from leaking out and contaminating the physician and the working environment. The design and construction of first seal 340, including the types of materials from which first seal 340 may be manufactured, are well known to those skilled in the art. An exemplary seal may include a single slit, but other types of slits, split holes, positioned slits, or penetrable seals may alternatively be used. For example, other sealing configurations include duckbills, slitted membranes (e.g., polystyrene, silicone, or another resilient polymeric material), or seals around catheters and wire guides, allowing any proximally moving fluid to pass through the channel. There are other designs that have the ability to prevent . A second seal 341 in this embodiment is located distal to the first seal 340 . Second seal 341 includes an opening 343 that fluidly engages first seal 340 and central passageway 320 of wire lock assembly 310 . An opening 343 in second seal 341 allows first seal 340 to flex into second seal 341 during use of central passageway 320 of wire lock assembly 310 . This embodiment may be advantageous when used in ports that have a nominal difference between the opening of the port and the accessory channel with the port. The dimensions of opening 343 in second seal 341 may be determined based on the diameter of the port for use with this embodiment of wire lock assembly 310 .

26A and 26B show perspective views of top surface 371 and bottom surface 373, respectively, of middle section 316 of wire lock assembly 310. FIG. Referring to FIG. 26A, middle section 316 is fluidly secured to both top opening 362 of top section 318 of wire lock assembly to form a central passageway when top section 318 and middle section 316 are secured together. It includes a communicating intermediate opening 372 . As shown, intermediate section 316 includes a raised generally rounded surface 356 that extends around a peripheral section of intermediate opening 372 . Raised rounded surface 356 includes a tapered portion and extends from intermediate opening 372 to the edge of the intermediate section. When the intermediate section 316 is mated with the upper section 318 of the wire lock assembly 310, the space created by the tapered raised rounded surface 356 and the upper section 318 of the wire lock assembly 10 provides a non-linear wire guide path. It is formed. Intermediate section 316 of wire lock assembly 310 further includes a flat edge 358 positioned adjacent intermediate opening 372 . The intermediate section 16 further includes a cavity 375 on the opposite side for receiving the wire guide when the wire guide is placed in the wire guide locking tail lock. Apertures 377, 379 for wire guide tail locks 328, 330 are located in the middle section 316 and are located on opposite sides. A shaping element 376 is located on the opposite side of the top surface 371 of the intermediate section 316 . Molded elements 376 are configured to engage corresponding elements of upper section 318 of wire lock assembly 310 . Referring now to FIG. 8B, bottom section 373 of middle section 316 includes wells 374 for receiving first seal 340 and second seal 341 . A shaping element 378 is located on the opposite side of the bottom surface 373 of the intermediate section 316 . Molded elements 378 are configured to engage corresponding elements of bottom section 314 of wire lock assembly 310 .

FIG. 27 shows another embodiment of wire lock assembly 410 . In this embodiment, wire lock assembly 410 includes body 412 having a quasi-hemispherical shape. However, in alternate embodiments, the body 412 of the wire lock assembly 410 may include other geometries. As shown in this embodiment, a central passageway 420 is disposed within the body 412 of the wire lock assembly 410 to accommodate a wire guide, catheter, or similar type elongated medical device (hereinafter "wire guide"). (collectively referred to as ). Within the body 412 of the wire lock assembly is a non-linear wire guide locking passage 413 leading to a wire guide locking slot 415 for the wire guide. When the wire lock assembly 410 is attached to a medical device such as an endoscope, wire guides that extend into the working channel of the medical device may also extend into the central passageway 420 . In this position, the wire guide can be placed within the non-linear wire guide locking path. Body 412 of wire lock assembly 410 includes a notch 422 located within upper section 418 of body 412 . Notch 422 helps facilitate positioning of the wire guide within a non-linear wire guide locking path formed within body 412 of wire lock assembly 410 . In the exemplary embodiment, non-linear path 413 and wire guide locking slot 415 create a three-point bending of the wire guide that automatically positions the wire guide in a locked position. As explained below, the configuration of the non-linear wire guide locking track prevents the wire guide from being damaged because the wire guide is not pinched between the opposing surfaces of the wire guide locking track. Further, after passing through the wire guide locking path 13 and being positioned within the wire guide locking slot 415, the wire guide is automatically in the locked position. An attachment mechanism 438 is provided to facilitate connection between the wire lock assembly 410 and a port of a second medical device. The body 412 of the wire lock assembly 410 is located on the opposite side of the biopsy cap rim to facilitate attachment of the device to the endoscope and to provide better grip of the biopsy cap. It further includes finger grooves 478 for squeezing.

FIG. 28 shows one embodiment of a wire lock assembly 510. As shown in FIG. In this embodiment, wire lock assembly 510 includes body 512 having a quasi-hemispherical shape. The body 512 of the wire lock assembly 510 may be shaped in a particular configuration, the wire lock assembly having a bottom section 514, a middle section 516 and a top section 518. However, in alternate embodiments, the body 512 of the wire lock assembly 510 may include other geometries. As shown in this embodiment, central passageway 520 is disposed within body 512 of wire lock assembly 510 to accommodate a wire guide, catheter, or similar type elongated medical device (hereinafter "wire guide"). collectively). Within the body 512 of the wire lock assembly is a non-linear wire guide locking passage 513 leading to the wire guide locking slot 15 for the wire guide. When the wire lock assembly 510 is attached to a medical device such as an endoscope, wire guides that extend into the working channel of the medical device may also extend into the central passageway 520 . In this position, the wire guide can be placed within the non-linear wire guide locking path. Body 512 of wire lock assembly 510 includes a notch 522 located within upper section 518 of body 512 . Notch 522 helps facilitate positioning of the wire guide within a non-linear wire guide locking path formed within body 512 of wire lock assembly 510 . In an exemplary embodiment, non-linear path 513 and wire guide locking slot 515 create a three-point bending of the wire guide that automatically positions the wire guide in a locked position. As explained below, the configuration of the non-linear wire guide locking track prevents the wire guide from being damaged because the wire guide is not pinched between the opposing surfaces of the wire guide locking track. Further, after passing through the wire guide locking path 513 and being positioned within the wire guide locking slot 515, the wire guide is automatically in the locked position. A flexible spine 580 is disposed on the surface of the body of wire lock assembly 510 . In one embodiment, flexible spine 580 is located on the bottom surface of the device. The flexible spine 580 may provide stress relief around the port when placed in a second medical device such as an endoscope.

The body 512 of the wire lock assembly 510 further includes two side wings 524,526 containing wire guide tail locks 528,530. Side wings 524, 526 allow a user to grasp a surface to attach and remove wire lock assembly 510 to and from a port of a medical device. As shown, side wings 524, 526 have generally rounded surfaces. However, those skilled in the art will appreciate that other configurations may be used for the side wings. Wire guide tail locks 528 , 530 are located within body 512 of wire lock assembly 510 and are located on opposite sides of body 512 of wire lock assembly 510 . In some embodiments, wire guide tail locks 528, 530 may include a single opening or multiple openings. The wire guide tail locks 528, 530 allow the locked wire guide to loop over the body 512 of the wire lock assembly 510 and be locked in a downward or upward position.

Figure 29 shows an alternative embodiment of a seal 640 for use with a wire lock assembly. The seal includes a first planar surface 642 and a second surface 644 having a concave, bowl-like configuration. In this embodiment, the second surface 644 may allow for greater distribution of connection points when the wire lock assembly is placed on the second medical device. In particular, the bowl-shaped second surface 644 is positioned within the opening of the connection port of the second medical device. This configuration may also help provide a proper seal when the wire lock assembly is to be placed on multiple medical devices having connection ports of varying sizes.

30A and 30B show an alternative embodiment of wire lock assembly 710. FIG. In this embodiment, wire lock assembly 710 includes body 712 having a quasi-hemispherical shape. The body 712 of the wire lock assembly 710 may be shaped to a particular configuration and has a bottom section 714 , a middle section 716 and a top section 718 of the wire lock assembly 710 . However, in alternate embodiments, the body 712 of the wire lock assembly 710 may include other geometries. As shown in this embodiment, central passageway 720 is disposed within body 712 of wire lock assembly 710 and accommodates a wire guide, catheter, or similar type elongated medical device (hereinafter "wire guide"). collectively). Within the body 712 of the wire lock assembly 710 is a non-linear wire guide locking passage 713 leading to a wire guide locking slot 715 for the wire guide. When the wire lock assembly 710 is attached to a medical device such as an endoscope, wire guides that extend into the working channel of the medical device may also extend into the central passageway 720 . In this position, the wire guide can be placed within the non-linear wire guide locking path 720 . Body 712 of wire lock assembly 710 includes a notch 722 located within upper section 718 of body 712 . Notch 722 helps facilitate positioning of the wire guide within a non-linear wire guide locking path formed within body 712 of wire lock assembly 710 . Wire guide locking slots 715 , 717 are located on opposite sides of wire guide locking assembly 710 . Wire guide locking slots 715, 717 include snap-fit locking mechanisms 768 that further facilitate locking of the wire guides.

The body 712 of the wire lock assembly 710 further includes two side wings 724,726. Side wings 724, 726 allow a user to grasp a surface to attach and remove wire lock assembly 710 to and from a port of a medical device. As shown, side wings 724, 726 have generally rounded surfaces. However, those skilled in the art will appreciate that other configurations may be used for the side wings 724,726. As shown in FIGS. 30A and 30B, a pair of wire guide tail locks 728, 730 are positioned within the middle section 726 of the body 712 of the wire lock assembly 710 and are positioned adjacent to each other. In some embodiments, wire guide tail locks 728, 730 may include a single opening or multiple openings. The wire guide tail locks 728 , 730 allow the locked wire guides to loop around the body 712 of the wire lock assembly 710 and be locked in position across the central passageway 720 .

31A and 31B show rear views of the wire guide assembly 710. FIG. As shown, the wire lock assembly 710 includes wire guide locking slots 715, 717 located on opposite sides of the wire guide locking assembly 710, a central channel 720, two side wings 724, 726; It includes an attachment mechanism 738 and a seal 740 located within the body 712 of the wire lock assembly 710 . A non-linear wire guide locking path 713 is located within the body 712 of the wire guide assembly 710 and leads to a wire guide locking slot 715 for the wire guide. Attachment mechanism 738 facilitates connection between wire lock assembly 710 and an access port of a second medical device. In this embodiment, attachment mechanism 738 is configured to engage a port of an endoscope. As shown, attachment mechanism 738 includes a groove 742 formed in bottom section 714 of wire lock assembly 710 . A snap-fit locking mechanism 744 is provided within groove 742 of attachment mechanism 738 to provide a more secure fit between the medical device and the port of the second medical device. A protrusion 746 having a thickness relative to the body 712 of the wire lock assembly 710 is positioned below the attachment mechanism 738 . In this embodiment, protrusion 746 has a quasi-hemispherical configuration and includes edge 747 that extends beyond the perimeter of groove 742 of attachment feature 738 . Protrusions 746 help prevent unwanted rotation of the wire lock assembly relative to the housing of the second medical device. The dimensions of attachment mechanism 738 and protrusion 746 may vary based on the dimensions of the second medical device. There is an angled ramp 760 in the groove 742 of the attachment mechanism 738 of the wire lock assembly 710 . The angled ramp 760 allows the wire lock assembly 710 to be secured to a second medical device by sliding the wire lock assembly 710 over the port of the second medical device.

The seal 740 is in fluid engagement with the central passageway 720 of the wire lock assembly 710 to allow working of the second medical device without impeding insertion or movement of a wire guide, catheter or similar elongated device. It is configured to restrict leakage of any fluid that may be present within the channel. This configuration can be particularly advantageous in preventing bodily fluids such as bile and blood from leaking out and contaminating the physician and the working environment. The design and construction of seal 740, including the types of materials from which seal 740 may be manufactured, are well known to those skilled in the art. In this embodiment, seal 740 is positioned between bottom portion 714 and middle portion 716 of wire lock assembly 710 . Although the exemplary seal 740 may include a single slit, other types of slits, split holes, positioned slits, or penetrable seals may alternatively be used. For example, other sealing configurations include duckbills, slitted membranes (e.g., polystyrene, silicone, or another resilient polymeric material), or seals around catheters and wire guides, allowing any proximally moving fluid to pass through the channel. There are other designs that have the ability to prevent . The seal 740 of this embodiment includes two generally planar surfaces. There is a notch 759 in the raised surface 756 located in the middle section 716 of the body 712 of the wire guide locking assembly 710 .

32 shows a side view of wire guide assembly 710. FIG. As shown, wire lock assembly 710 includes wire guide locking slot 715 , attachment mechanism 738 and wire guide tail lock 728 . Wire guide locking slots 715 are in side wings 724 of wire lock assembly 710 . Wire guide locking slot 715 includes a snap-fit locking mechanism 768 that further facilitates locking of the wire guide. The upper portion 718 and middle portion 716 of the wire lock assembly form a wire guide locking passage 713 leading to wire locking slot 715 . The wire guide locking passage 713 includes a raised surface 756 located in the middle section 716 of the wire lock assembly. A raised rounded surface 756 extends around the periphery of central channel 720 and has a generally semi-hemispherical shape. There is a notch 759 in the raised surface 756 located in the middle section 716 of the body 712 of the wire guide locking assembly 710 . Notch 759 is located in the non-linear path.

FIG. 33 shows a cross-sectional view of wire guide assembly 710 . As shown, this view is from the rear of body 712 of wire guide assembly 710 . Wire lock assembly 710 includes a central passageway 720 , an attachment mechanism 738 , and a seal 740 located within body 712 of wire lock assembly 710 . The upper portion 718 and middle portion 716 of the wire lock assembly form a wire guide locking passage 713 leading to wire locking slot 715 . The wire guide locking passage 713 includes a raised surface 756 located in the middle section 716 of the wire lock assembly. A raised rounded surface 756 extends around the periphery of central channel 720 and has a generally semi-hemispherical shape. As shown, raised rounded surface 756 includes a taper extending from central path 720 to the outer peripheral edge of intermediate section 716 . The tapered section of raised rounded surface 756 increases in diameter as it widens toward the outer periphery of intermediate section 716 . Raised rounded surface 756 includes a tapered, generally rounded surface extending around the perimeter of the intermediate opening. The wire lock assembly 710 further includes a flat edge 758 located in the middle section 716 of the wire lock assembly. When the wire guides are secured within the wire guide locking slots 715, 717, the flat edges 758 provide a flat edge between the wire guide and the catheter as the user pulls the catheter up to perform a catheter exchange. May be used as a wedge. A notch 759 is provided in the rounded surface 756 of the middle section 716 of the body 712 of the wire lock assembly 710 . As shown, the notches are positioned along the wire guide locking path 713 to help prevent the wire guides from inadvertently moving from their locked positions within the wire guide locking slots 715,717. do. Wire guide tail locks 728, 730 are located within the middle section 716 of the body 712 of the wire guide assembly. As shown in FIG. 33, the wire guide tail locks 728, 730 are in communication with the seal 740 and extend across a central passageway 720 disposed within a portion of the intermediate section 716 of the body 712 of the wire lock assembly 710. are placed.

FIG. 34 shows a cross-sectional view of wire guide assembly 710 . As shown, this view is from the side of body 712 of wire guide assembly 710 . Wire lock assembly 710 includes a central passageway 720 , an attachment mechanism 738 , and a seal 740 located within body 712 of wire lock assembly 710 . The upper portion 718 and middle portion 716 of the wire lock assembly form a wire guide locking passage 713 leading to wire locking slot 715 . A wire guide tail lock 728 is positioned within a portion of the middle section 716 of the body 712 of the wire lock assembly 710 . In this embodiment, wire guide tail lock 728 forms an angled passageway 729 that communicates with seal 740 . Angled pathway 729 facilitates engagement of the proximal end of the wire guide with seal 740 when the proximal end of the wire guide is positioned within wire guide tail lock 728 . This engagement with seal 740 locks the proximal end of the wire guide within wire guide tail lock 728 and provides a tactile indication to the user that the proximal end of the wire guide is secured. A notch 759 is provided in the rounded surface 756 of the middle section 716 of the body 712 of the wire lock assembly 710 . As shown, the notch 759 is positioned along the wire guide locking path 713 to help prevent the wire guide from inadvertently moving from its locked position within the wire guide locking slot 715. do.

FIG. 35 shows an exemplary embodiment of a wire lock assembly 710 disassembled. Wire lock assembly 710 is formed of a suitable material such as plastic. The material may be molded into a particular shape, and the wire lock assembly 710 has a bottom section 714, a middle section 716 and a top section 718. A seal 740 is provided within the body 712 of the wire lock assembly 710 . In this embodiment, seal 740 is secured between middle section 716 and bottom section 714 of wire lock assembly 710 and is in fluid communication with central passageway 720 of wire lock assembly 710 . Although the exemplary embodiment shown here is constructed from three pieces that snap together, the wire lock assembly 10 can be made from one or more pieces that can be secured together in any manner. good. For example, the parts may be ultrasonically bonded, thermally bonded, bonded together, or secured in any other manner.

The novel features of the disclosed medical devices can be used successfully in a variety of applications.
In fact, the medical devices disclosed herein can be used in a wide variety of different medical procedures. In particular, the disclosed medical devices can be used in medical procedures that require securing one or more elongated medical devices, such as catheters or wire guides, either to a patient or to another medical device. can.

Other undisclosed or incidental details in the structure and arrangement of the various elements of the disclosed embodiments of the present invention are disclosed only so long as those elements possess the necessary attributes to perform as disclosed. None are believed to be critical to the realization of the advantages of the present invention. The selection of these and other details of construction, in view of the present disclosure, is believed to be well within the capabilities of those having rudimentary skill in the art. The illustrative embodiments of the invention have been described in considerable detail for the purpose of disclosing the actual, operational structure and enabling the invention to be effectively practiced. The designs described herein are intended to be exemplary only. The novel features of this invention may be incorporated in other structural forms without departing from the spirit and scope of the invention. Indeed, different features of the disclosed embodiments may be integrated into one structure or provided as separate parts. For example, the disclosed embodiments may be paired with a second medical device, such as a disassembly tool. The disassembly tool may be coupled to the medical device by mechanical attachments including, but not limited to, the use of magnets, adhesives, snap fit mechanisms, and the like. Alternative mechanisms may also be used to facilitate the connection between the two devices.

Claims (14)

A wire lock assembly for an access port of an elongated medical device, comprising:
a body having an exterior surface, an interior surface, and a central opening disposed within the body;
an attachment mechanism disposed within the exterior surface of the body, the attachment mechanism having an open end;
at least one notch positioned in the body and positioned proximate the central opening;
at least one seal supported within the interior surface of the body and in communication with the central opening, the seal including a passageway within the seal;
the interior surface of the body defines a non-linear path for securing one or more wire guides;
The non-linear path of the inner surface is positioned to distribute forces applied to at least one of the one or more wire guides such that at least one of the one or more wire guides is automatically locked. A wire lock assembly defined by a plurality of defined bends. 2. The wire lock assembly of claim 1, wherein the non-linear path of the inner surface is defined by one or more bends. 2. The wire lock assembly of claim 1, wherein said one or more wire guides take said non-linear path by bending. 2. The wire lock assembly of claim 1, wherein the interior surface of the body places the one or more wire guides into a flexed condition. 2. The wire lock assembly of claim 1, wherein said at least one notch is positioned within said non-linear path. The wire lock assembly of Claim 1, wherein the attachment mechanism includes a ramp. 2. The wire lock assembly of claim 1, wherein projections are located on the periphery of the attachment mechanism. The wire lock assembly of Claim 1, wherein the body includes a top section, a middle section, and a bottom section. 9. The wire lock assembly of claim 8, wherein said interior surface of said non-linear path is formed between said upper section and said intermediate section of said body. 2. The wire lock assembly of claim 1, wherein said attachment mechanism includes at least one ramp near said open end. The wire lock assembly of claim 1, wherein the elongated medical device is selected from the group consisting of catheters, endoscopes, and introducer sheaths. 2. The wire lock assembly of claim 1, including one or more seals. 2. The wire lock assembly of claim 1, including one or more passageways in said body disposed across said central opening, said one or more passageways including angled interior surfaces. 2. The wire lock assembly of claim 1, including one or more passageways within said body disposed parallel to said central opening.

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